Background

Counterfeiting is a particularly lucrative trade for criminals wanting to exploit the reputation of genuine medicines for their own ends. Counterfeiters are interested in selling a product which can be mistaken for the real thing on the basis of its external appearance; they have no interest in ensuring that it contains the correct ingredients. They can manufacture products in backstreet operations at a fraction of the cost of genuine medicines, without having to abide by the detailed and stringent legal provisions governing the manufacture of genuine medicines. In many countries the risk of being caught is relatively low, and so producing fake drugs can be even more lucrative than trafficking in illegal drugs. These illegal backstreet operations are often backed by highly professional criminal networks.

Unlike other cases of piracy, counterfeiting or fraud, patients who buy fake medicines may have bought them in good faith. The counterfeiter’s sole aim is to defraud the patient without any regard for their health or life.

Any successful medicine can be targeted by the counterfeiters- this includes both ethical (patented) medicines and generics (medicines sold under a different name after the original manufacturer’s patent has expired). High value prescription-only medicines for treating conditions such as cancer or AIDS, are particularly attractive to the fraudsters. Antibiotics are probably the most commonly faked medicines worldwide. Increasingly lifestyle medicines such as those treating erectile dysfunction are also targeted.

Therefore all patients are exposed to some potential risk, even with a robust system of regulation. In particular, patients wanting to buy medicines online or when travelling abroad should make sure they are fully aware of all of the risks before buying.

The World Health Organization (WHO) and the International Federation of Pharmaceutical Manufacturers’ Associations (IFPMA) define a counterfeit medicine as “a medicine which is deliberately and fraudulently mislabelled with respect to identity and/or source.”

Put simply, counterfeit medicines are medicines which come neither from the original manufacturer nor in the standard packaging, and without the relevant legal and regulatory control.

The spectrum of counterfeit medicines spans from complete fakes, which are wholly made by the counterfeiter, to genuine products whose expiry date has been falsely extended.

Other examples include:

• medicines which contain too high or too low a dose of the active ingredient medicines which contain no active ingredient
• medicines which contain a different active ingredient from the one(s) claimed
• medicines which are sold in false packaging, blister packs and/or with incorrect patient information

Without additional information, healthcare professionals as well as patients may struggle to identify a counterfeit if its external appearance closely matches that of the genuine medicine.

Generic medicines are products sold under a different name after the original manufacturer’s patent has expired. These medicines contain the same active ingredient as the original. Many reputable companies legally manufacture these to a quality comparable with the original. However generic medicines can also be targeted by the counterfeiters.

It is increasingly common for criminal organisations to offer products which they claim have the same medicinal effect as a genuine medicine or its active ingredient. Extreme caution should be exercised if you are offered prescription-only medicines (POM) without a prescription from an internet retailer who claims the product is equivalent to a medicine you are familiar with. Always consult your healthcare professional to ascertain whether the offer is of a genuine medicine and read up on reliable internet pharmacies before ordering any medicine online.

Medicines are designed to treat medical conditions and help people get well. It is obvious that counterfeiters are not interested in producing a product of the same quality as the original. Counterfeit medicines are inherently dangerous, either because they contain toxins or impurities, or because they are of a lesser quality than the original.

Even if the product does contain some active ingredients, they may be inadequate in quality or quantity, causing a vaccination or test to fail or leading to resistance against the genuine active ingredient.

Insufficient information about the correct indication or usage of a drug may mean that even a genuine treatment can to pose considerable risk to the user and potentially cause harm. In some extreme cases, dangerous substances are added in order to produce an “effect” - or rather a side effect of no therapeutic value - resembling that of the original product.

Using counterfeit medicines is always a game of Russian roulette.

• Nausea can be a side effect of a genuine product used to treat severe conditions, and patients who are prescribed such medicines will be aware of this. This can be exploited by counterfeiters who might deceive patients by adding toxins to their counterfeit product to produce a similar effect.
• Counterfeit drugs, such as those used to treat erectile dysfunction, might contain versions of the original active ingredient, which will not have been clinically tested. The counterfeiter might also add several active ingredients. Both of which might lead to a “visible” effect; they might even appear more effective than the genuine product. However, what is not known is what the short and long term health risks are of such untested variants or indeed what substance the patient will have been taking.